A Phase Ib Study of Neoadjuvant of Cetuximab Plus Motolimod and Cetuximab Plus Motolimod Plus Nivolumab

October 23, 2019 updated by: Celgene

A Phase Ib Study of Neoadjuvant Immune Biomarker Modulation With Cetuximab Plus Motolimod and With Cetuximab Plus Motolimod Plus Nivolumab

Protocol VRXP-A106 will enroll patients with Stage II-IVA head and neck cancer patients who will be treated with surgical resection. Cetuximab and motolimod (Cohort 1); and cetuximab, motolimod, and nivolumab (Cohort 2) will be administered for a 3-4 week period before surgery. The primary objective of the study is to determine the extent to which the administration of neoadjuvant motolimod plus cetuximab and motolimod plus cetuximab and nivolumab modulates immune biomarkers (NK, mDC and T cell activation as well as tumor infiltration and serum cytokines) in peripheral blood and head and neck cancer tumors. An exploratory objective of the study is to assess whether modulation of biomarkers as described above can predict anti-tumor response.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previously untreated stage II, III, or IVA histologically or cytologically confirmed squamous cell carcinoma of the head and neck
  • Primary tumors of the oral cavity, oropharynx, hypopharynx, or larynx
  • Macroscopic complete resection of the primary tumor must be planned
  • Age ≥ 18 years
  • ECOG performance status 0-1
  • Adequate hematologic, renal and hepatic function
  • Have signed written informed consent

Exclusion Criteria:

  • Subjects who fail to meet inclusion criteria
  • Primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors
  • Prior severe infusion reaction to a monoclonal antibody
  • Pregnancy or breastfeeding
  • Evidence of distant metastasis
  • Any other malignancy active within 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix, DCIS or LCIS of the breast
  • Prior history of head and neck cancer
  • Prior therapy with motolimod, nivolumab, or other agents targeting PD-1/PD-L1
  • Prior therapy targeting the EGFR pathway
  • Acute hepatitis, known HIV, or active uncontrolled infection
  • Patients with active autoimmune disease
  • History of uncontrolled cardiac disease within prior 6 months
  • Uncontrolled peptic or gastric ulcer disease, or gastrointestinal bleeding within prior 6 months
  • Active alcohol abuse or other illness or circumstance that carries a likelihood of inability to comply with study treatment and follow-up or otherwise compromise the study's objectives
  • Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of study treatment
  • Live vaccine within 30 days of planned start of study therapy
  • History of pneumonitis or interstitial lung disease
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motolimod plus cetuximab
Cohort 1: motolimod plus cetuximab
Drug: Cetuximab
Other Names:
  • Erbitux
Drug: Motolimod
Other Names:
  • VTX-2337
Experimental: Motolimod, cetuximab, and nivolumab
Cohort 2: motolimod, cetuximab, and nivolumab
Drug: Cetuximab
Other Names:
  • Erbitux
Drug: Nivolumab
Other Names:
  • Opdivo
Drug: Motolimod
Other Names:
  • VTX-2337

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in immune biomarkers including FcγR genotype, NK activation, tumor infiltration and serum cytokines, mDC, T cell activation, and tumor-antigen specific cytotoxic T lymphocyte induction.
Time Frame: change from baseline to up to 4 weeks
change from baseline to up to 4 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Anti-tumor response
Time Frame: Change from baseline to pre-surgery
Change from baseline to pre-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • https://clincancerres.aacrjournals.org/content/clincanres/early/2017/11/28/1078-0432.CCR-17-0357.full.pdf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2014

Primary Completion (Actual)

August 11, 2016

Study Completion (Actual)

October 31, 2016

Study Registration Dates

First Submitted

April 22, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (Estimate)

April 28, 2014

Study Record Updates

Last Update Posted (Actual)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 23, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VRXP-A106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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